Bayer says FDA grants priority review designation for finerenone

Bayer said on Thursday that ​the U.S. Food and ‌Drug Administration had accepted its supplemental ​New Drug Application ​for finerenone and granted ⁠priority review designation.

Reuters • May 21, 2026

BAYRY's Kerendia Label Expansion Application Gets Priority Review

Bayer wins FDA Priority Review for Kerendia label expansion in CKD tied to type I diabetes after strong phase III data.

Zacks Investment Research • a day ago

Bayer's KERENDIA® (finerenone) Granted Priority Review of Supplemental New Drug Application by U.S. FDA for Treatment of Adults with Type 1 Diabetes and Chronic Kidney Disease

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer Summary Bayer announced today that the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) and granted Priority Review designation for KERENDIA® (finerenone), which is being investigated for the treatment of adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). Key Facts The sNDA was supported by the Phase III FINE-ONE trial, which showed KERENDIA significantly reduced urine albumin-to-creatinine rati.

Business Wire • May 21, 2026

ASCO 2026: Bayer to Present New Data Across Oncology Portfolio

WHIPPANY, N.J.--(BUSINESS WIRE)--ASCO 2026: Bayer to Present New Data Across Oncology Portfolio.

Business Wire • May 21, 2026

BAYRY or RHHBY: Which Is the Better Value Stock Right Now?

Investors interested in Large Cap Pharmaceuticals stocks are likely familiar with Bayer Aktiengesellschaft (BAYRY) and Roche Holding AG (RHHBY). But which of these two companies is the best option for those looking for undervalued stocks?

Zacks Investment Research • May 20, 2026

Bayer Gets FDA Priority Review for Asundexian NDA in Stroke Prevention

BAYRY gains FDA Priority Review for asundexian NDA after phase III data showed a 26% cut in ischemic stroke risk without more major bleeding.

Zacks Investment Research • May 19, 2026

FDA Grants Priority Tag to Bayer's Oncology Drug for First-Line NSCLC

BAYRY wins FDA priority review for sevabertinib in first-line HER2-mutant NSCLC, building momentum for the oral TKI.

Zacks Investment Research • May 19, 2026

Bayer Granted Priority Review by U.S. FDA for Asundexian in Patients After a Non-Cardioembolic Ischemic Stroke or Transient Ischemic Attack

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer: WHAT'S HAPPENING Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) and granted Priority Review designation for its investigational oral Factor XIa (FXIa) inhibitor, asundexian, for the prevention of secondary stroke in patients following a non-cardioembolic ischemic stroke or transient ischemic attack (TIA). The NDA is based on positive results from the global, pivotal Phase III OC.

Business Wire • May 19, 2026

Bayer agrees to pay $133 million for PCB cleanup in two states

Bayer's Monsanto unit on Monday said it ​would pay at least $133 million to settle Michigan and Rhode Island's claims that the company ‌contaminated the states' natural resources with toxic chemicals that are known to have dangerous health effects.

Reuters • May 18, 2026

Bayer Introduces Midol® in Motion, Empowering Menstruators to Find PMS Relief Through Movement

WHIPPANY, N.J.--(BUSINESS WIRE)--Up to 90% of menstruators experience PMS symptoms1, many of which can meaningfully impact day‑to‑day life. Bayer today announced the launch of Midol® in Motion, a campaign focused on helping people better understand and relieve 7 common PMS symptoms – period cramps, bloating, fatigue, backaches, muscle aches, headaches, and water retention – through a combination of symptom relief and supportive movement. Midol® in Motion is grounded on consumer experience and r.

Business Wire • May 15, 2026